Vela Diagnostics have developed a molecular-based assay to diagnose for Covid-19 and have applied to the US FDA for its approval under emergency use authorisation (EUA). Vela has announced that customers can pre-order the Virokey™ SA201 SARS-CoV-2 RT-PCR kit while this application is in process. 

SA201 SARS-CoV-2 RT-PCR Test (Research Use Only) will be able to detect and differentiate the SARS-CoV-2 from other closely related coronaviruses such as SARS-CoV and MERS-CoV. To enable high-throughput processing of 96 samples in 4 hours, the test is configured for an automated workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument (ABI 7500 Fast Dx) or the Sentosa™ SA201.

The Sentosa™ SA201 platform also supports other tests such as the Sentosa™ SA201 HSV-1/2 PCR Test (U.S. FDA cleared) and the previously authorized Sentosa™ SA201 ZIKV RT-PCR Test (for use under Emergency Use Authorization from the U.S. FDA). As time-to-market is critical to address the urgent need for the test, a manual kit will also be made available to facilitate the fast adoption of the test by laboratories with existing ABI 7500 Fast Dx PCR instruments.